The FDA on June 16, 2021, approved AYVAKIT® for adult patients with advanced Systemic Mastocytosis, including patients with aggressive Systemic Mastocytosis, Systemic Mastocytosis with an associated hematological neoplasm, and Mast Cell Leukemia. AYVAKIT® is a product of Blueprint Medicines Corp.
Category: FDA Approvals
TRUSELTIQ® (Infigratinib)
The FDA on May 28, 2021, granted accelerated approval to TRUSELTIQ®, a kinase inhibitor, for adults with previously treated, unresectable locally advanced or metastatic Cholangiocarcinoma with a Fibroblast Growth Factor Receptor 2 (FGFR2) fusion or other rearrangement, as detected by an FDA-approved test. TRUSELTIQ® is a product of QED Therapeutics, Inc.
The FDA also approved FoundationOne® CDx (Foundation Medicine, Inc.) for selection of patients with FGFR2 fusion or other rearrangement as a companion diagnostic device for treatment with TRUSELTIQ®.
LUMAKRAS® (Sotorasib)
The FDA on May 28, 2021 granted accelerated approval to LUMAKRAS®, a RAS GTPase family inhibitor, for adult patients with KRAS G12C mutated locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC), as determined by an FDA approved test, who have received at least one prior systemic therapy. LUMAKRAS® is a product of Amgen, Inc.
RYBREVANT® (Amivantamab-vmjw)
The FDA on May 21, 2021 granted accelerated approval to RYBREVANT® for adult patients with locally advanced or metastatic Non-Small Cell Lung Cancer, with EGFR exon 20 insertion mutations, that progressed on or after platinum-based chemotherapy. RYBREVANT® is a product of Janssen Biotech, Inc.
OPDIVO® (Nivolumab)
The FDA on May 20, 2021 approved OPDIVO® for patients with completely resected Esophageal or GastroEsophageal Junction (GEJ) cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy. OPDIVO® is a product of Bristol-Myers Squibb Company.
KEYTRUDA® (Pembrolizumab)
The FDA on May 5, 2021 granted accelerated approval to KEYTRUDA® (Pembrolizumab) in combination with Trastuzumab, Fluoropyrimidine and Platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive Gastric or GastroEsophageal Junction (GEJ) adenocarcinoma. KEYTRUDA® is a product of Merck & Co.
ZYNLONTA® (Loncastuximab tesirine-lpyl)
The FDA on April 23, 2021 granted accelerated approval to ZYNLONTA®, a CD19-directed antibody and alkylating agent conjugate, for adult patients with Relapsed or Refractory Large B-Cell Lymphoma after two or more lines of systemic therapy, including Diffuse Large B-Cell Lymphoma (DLBCL) not otherwise specified, DLBCL arising from Low Grade Lymphoma, and High-Grade B-cell Lymphoma. ZYNLONTA® is a product of ADC Therapeutics SA.
JEMPERLI® (Dostarlimab-gxly)
The FDA on April 22, 2021 granted accelerated approval to JEMPERLI® for adult patients with MisMatch Repair deficient (dMMR) recurrent or advanced Endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior Platinum-containing regimen. JEMPERLI® is a product of GlaxoSmithKline LLC.
TRODELVY® (Sacituzumab govitecan)
The FDA on April 13, 2021, granted accelerated approval to TRODELVY® for patients with locally advanced or metastatic Urothelial Cancer (mUC) who previously received a Platinum-containing chemotherapy and either a Programmed Death receptor-1 (PD-1) or a Programmed Death-Ligand 1 (PD-L1) inhibitor. TRODELVY® is a product of Immunomedics Inc.